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The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study)

NCT02334241 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-08-31

No results posted yet for this study

Summary

The aim of this study is to demonstrate, during a 12-week follow-up, a greater efficacy of using Sorbact® dressing technology in addition to best local cares compared to best local cares alone in the management of diabetic foot ulcers

Conditions

  • Foot Ulcer, Diabetic

Interventions

DEVICE

Sorbact®

Sorbact® is available in many types and sizes. These different presentations are available allowing management of quite all types of wounds of various anatomical locations, sizes or depths. Application of any of these presentations is allowed and may change during study course according to wound evolution.

DEVICE

Best local cares

Participating centers will provide a list of dressings they planned to use in the best local cares arm. This list must be validated by the study Steering Committee members

Sponsors & Collaborators

  • RCTs

    collaborator INDUSTRY

  • INRESA Pharma

    lead INDUSTRY

Principal Investigators

  • Jan APELQVIST · University Hospital of Malmö

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-09-30
Completion
2017-04-30

Countries

  • Czechia
  • France
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02334241 on ClinicalTrials.gov